Pulmonx Corporation | September 05, 2022
Pulmonx Corporation a global leader in minimally invasive treatments for severe lung disease, announces the presentation of interim results from the CONVERT Study at the 2022 European Respiratory Society International Conference. Data on the first 40 patients in the study demonstrated that treatment with the AeriSeal System successfully converted the collateral ventilation status in 78% of patients who were subsequently treated with Zephyr Valves.
The AeriSeal System is used to close collateral air channels in a target lung lobe of a patient with severe COPD/emphysema, making the patient eligible to then undergo Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr Valves. Patients whose lungs have untreated collateral ventilation are currently ineligible for treatment with Zephyr Valves and have limited options once medical management alone does not control symptoms. Once the target lobe is converted from CV+ to CV-, patients can be treated with Zephyr Valves, which has been shown to improve lung function, quality of life, and exercise capacity for patients with severe COPD/emphysema.
The CONVERT study uses the AeriSeal System to close collateral air flow. Once the treated lobe tests negative for collateral ventilation Zephyr Valves are implanted to address hyperinflation of that target lobe to ease emphysema symptoms without major surgery. Successfully converted patients who received Zephyr Valves had clinically meaningful Target Lobe Volume Reduction with a mean reduction of greater than one (1) liter. The CONVERT trial is ongoing and full clinical outcomes of BLVR with Zephyr Valves were not reported at this time. However, results recently published from a single-center feasibility study at Macquarie University Hospital in Australia showed that the AeriSeal System successfully closed collateral air channels and allowed for successful clinical outcomes after treatment with Zephyr Valves.2 At 6 months, AeriSeal and Zephyr Valve treated CV+ patients experienced clinically meaningful improvements similar to improvements in CV- patients treated with Zephyr Valves alone.2 Improvements included
Lung function (FEV1 increase of 19.7%, Residual Volume decrease of 16.2%)
Quality of life (SGRQ score decrease of 15.1 points)
Exercise capacity (Six-Minute Walk Distance increase of 77.2 meters)
There were no serious adverse reactions experienced by patients in the Australian feasibility study; 20% of patients in the CONVERT Study experienced an inflammatory response following AeriSeal treatment - all were transient, medically managed, and resolved. The available data suggest that patients with collateral ventilation can undergo successful BLVR with Zephyr Valves following closure of the fissure gap with the AeriSeal System.
“This is very promising news for patients with advanced COPD. We know that treatment with Zephyr Valves can provide long-term improvements in lung function, breathing, and quality of life, but for patients with collateral ventilation, this minimally invasive treatment has not been available as an option,” explains Dr. Michela Bezzi, Department Head and Director Interventional Pulmonology - ASST Spedali Civili, University Hospital, Brescia, Italy. “Having a technology like the AeriSeal System to convert collateral ventilation positive patients to negative status means we can provide a treatment to patients who currently have very few options.”
“This work reflects our continued commitment to developing and testing new medical technologies to help patients with severe lung disease breathe easier and have better quality of life. These early study results are encouraging and move us closer to the goal of helping severe emphysema patients who have collateral ventilation benefit from our proven Zephyr Valve treatment.”
Glen French, President and Chief Executive Officer of Pulmonx
About the CONVERT Study
CONVERT is a prospective, open-label, multi-center, single-arm study being conducted at up to 20 investigational sites. The study plans to enroll 140 subjects with severe emphysema and collateral ventilation in the target lobe. This protocol is designed to evaluate the utility of the AeriSeal System, which uses a synthetic polymer foam to occlude collateral air channels in a target lung lobe and convert the target lung lobe to having little to no collateral ventilation. Patients will then undergo Bronchoscopic Lung Volume Reduction with Zephyr Endobronchial Valves. Zephyr Valves are not effective if collateral ventilation (CV+) is present but once the target lobe is converted from CV+ to CV-, patients can be treated with Zephyr Valves which has been shown to improve lung function, quality of life, and exercise capacity for patients with severe COPD/emphysema.
About Zephyr Valves
The Zephyr Valve is a minimally invasive treatment option for severe COPD/emphysema. Zephyr Valves are placed via bronchoscopy to block off a diseased portion of the lung to prevent air from getting trapped and reduce hyperinflation, which allows the healthier lung tissue to expand and take in more air. This results in patients being able to breathe easier, be less short of breath, and have an improvement in their quality of life.1 National and global treatment guidelines for COPD include Endobronchial Valves like Zephyr Valves with the Global Initiative for Chronic Obstructive Lung Disease giving valves an ‘Evidence A’ rating. More than 25,000 patients have been treated with the Zephyr Valve worldwide.
About Pulmonx Corporation
Pulmonx Corporation is a global leader in minimally invasive treatments for severe lung disease. Pulmonx’s Zephyr® Endobronchial Valve, Chartis® Pulmonary Assessment System and StratX® Lung Analysis Platform are designed to assess and treat patients with severe emphysema/COPD who, despite medical management, are still profoundly symptomatic. Pulmonx received FDA premarket approval to commercialize the Zephyr Valve following its designation as a “breakthrough device.” The Zephyr Valve is commercially available in more than 25 countries, with over 100,000 valves used to treat more than 25,000 patients.
Viemed Healthcare, Inc. | July 06, 2022
Viemed Healthcare, Inc. a national leader in respiratory care and technology-enabled home medical equipment services, announced a third peer-reviewed and published study demonstrating the benefits of non-invasive ventilation at home The study, titled “Early Initiation of Non-Invasive Ventilation at Home Improves Survival and Reduces Healthcare Costs in COPD Patients with Chronic Hypercapnic Respiratory Failure: A Retrospective Cohort Study” was published in Respiratory Medicine, an internationally renowned scientific journal devoted to respiratory medical research.
“In addition to the significant clinical benefits demonstrated in previously published papers, this study demonstrates that NIVH improves health outcomes while simultaneously driving down overall healthcare costs. The study was also designed to investigate how the timing of NIVH initiation affected the outcomes. The results showed that the clinical and financial benefits of NIVH are greatest when therapy begins immediately following the diagnosis.”
Dr. William Frazier, Viemed’s Chief Medical Officer and co-author of the study
Using the 100% research identifiable fee-for-service Medicare claims from 2016 through 2020, the researchers found that using NIVH to treat chronic obstructive pulmonary disease with chronic hypercapnic respiratory failure is associated with significant reductions in mortality, hospitalizations, and total Medicare costs. In terms of cost-savings, Medicare expenditures for the year following NIVH initiation decreased by $5,484 compared to controls if treatment was begun within seven days of diagnosis. The cost reduction was $3,412 if NIVH was begun within 15 days of diagnosis. For patients whose therapy began more than 15 days after diagnosis, NIVH use was cost neutral and not associated with an increase in Medicare expenditures.
The primary clinical benefit was a reduced mortality in patients treated with NIVH. When a patient began therapy within seven days of diagnosis, the risk of death was reduced by 43%. Those patients who began therapy between eight and 15 days following diagnosis showed a mortality reduction of 31%, and patients who began therapy between 16 and 30 days following diagnosis showed a mortality reduction of 16%.
“NIVH is becoming widely accepted by clinicians as the standard of care for hypercapnic COPD-CRF treatment and this evidence supporting early initiation will help us to communicate the clinical and economic benefits to payors and partners,” said Casey Hoyt, Viemed’s CEO. “By accessing and treating more patients sooner, we can save lives, reduce hospital readmissions, and save money at the same time.”
ABOUT VIEMED HEALTHCARE, INC.
Viemed is a provider of in-home medical equipment and post-acute respiratory healthcare services in the United States. Viemed’s service offerings are focused on effective in-home treatment with clinical practitioners providing therapy and counseling to patients in their homes using cutting edge technology.
Harris Williams | August 01, 2022
Harris Williams, a global investment bank specializing in M&A advisory services, announces it is advising The CM Group, a portfolio company of NaviMed Capital (NaviMed), on its pending sale to OPEN Health, a portfolio company of Astorg. The CM Group is a leading medical communications platform offering a set of integrated solutions to the U.S. domestic biotech and pharma industries. The transaction is being led by Paul Hepper, Nick Owens, Lucas Scholl, Rob Crampton and Gabby Struckell of the Harris Williams Healthcare & Life Sciences Group.
“Investor interest in outsourced pharma commercialization services is driven by complex therapies becoming an increasing portion of new drug launches, declining access to physicians, and the increasing importance of directly reaching patient populations. Differentiated platforms such as The CM Group are benefiting disproportionally from these trends,” said Paul Hepper, a managing director at Harris Williams.
“The combination of OPEN Health and The CM Group brings together two best-in-class commercialization businesses, with stellar reputations in the industry and an exciting opportunity to service leading pharmaceutical companies globally,” said Nick Owens, a director at Harris Williams.
“Harris Williams was a phenomenal partner and exceeded our expectations throughout the transaction. The team’s knowledge of the sector and extensive buyer relationships led to an optimal outcome. We look forward to the next phase of growth with the OPEN Health and Astorg teams and are excited about building a global leader in pharma commercialization,”
Daniel Leonard, CEO of The CM Group
Grounded in science—and powered by the patient voice—The CM Group is an integrated healthcare agency of innovative and imaginative subject-matter experts dedicated to providing scientific and commercialization strategies and services to the life sciences industry.
NaviMed is a Washington, D.C.-based private capital firm with over $400 million of assets under management, focused exclusively on the healthcare industry. NaviMed invests in fast-growing lower-middle market healthcare businesses that it believes are poised to benefit from the reform and technology innovation reshaping the healthcare industry. The firm focuses on healthcare services, healthcare IT, hospital products and pharmaceutical services businesses. NaviMed targets profitable private companies with up to $10 million of EBITDA and double-digit revenue growth. NaviMed’s senior investment team has a track record of value creation spanning, in the aggregate, dozens of investments and more than $11 billion of enterprise value created over the course of their combined careers.
OPEN Health brings together deep scientific knowledge, global understanding, and broad specialist expertise to support its clients in improving health outcomes and patient wellbeing. OPEN Health is united as one flexible organization, harnessing the power of the collective to solve complex challenges.
Astorg is a European private equity firm with over €17 billion of assets under management. Astorg works with entrepreneurs and management teams to acquire market leading global companies headquartered in Europe or the U.S., providing them with the strategic guidance, governance and capital they need to achieve their growth plans. Enjoying a distinct entrepreneurial culture, a long-term shareholder perspective and a lean decision-making body, Astorg has valuable industry expertise in healthcare, software, technology, business services and technology-based industrial companies. Astorg has offices in London; Paris; New York; Frankfurt, Germany; Milan; and Luxembourg.
Harris Williams, an investment bank specializing in M&A advisory services, advocates for sellers and buyers of companies worldwide through critical milestones and provides thoughtful advice during the lives of their businesses. By collaborating as one firm across Industry Groups and geographies, the firm helps its clients achieve outcomes that support their objectives and strategically create value. Harris Williams is committed to execution excellence and to building enduring, valued relationships that are based on mutual trust. Harris Williams is a subsidiary of the PNC Financial Services Group, Inc.
The Harris Williams HCLS Group has experience across a broad range of sectors, including healthcare providers; payors and payor services; outsourced pharmaceutical services; medical device supply chain; healthcare IT; and pharmacy.
Harris Williams LLC is a registered broker-dealer and member of FINRA and SIPC. Harris Williams & Co. Ltd is a private limited company incorporated under English law with its registered office at 8th Floor, 20 Farringdon Street, London EC4A 4AB, UK, registered with the Registrar of Companies for England and Wales (registration number 07078852). Harris Williams & Co. Ltd is authorized and regulated by the Financial Conduct Authority. Harris Williams & Co. Corporate Finance Advisors GmbH is registered in the commercial register of the local court of Frankfurt am Main, Germany, under HRB 107540. The registered address is Bockenheimer Landstrasse 33-35, 60325 Frankfurt am Main, Germany. Geschäftsführer/Directors: Jeffery H. Perkins, Paul Poggi.Harris Williams is a trade name under which Harris Williams LLC, Harris Williams & Co. Ltd and Harris Williams & Co. Corporate Finance Advisors GmbH conduct business.
FUTURE OF HEALTHCARE
Azenta, Inc. | August 09, 2022
Azenta, Inc. announced that it has entered into a definitive agreement to acquire B Medical Systems S.á r.l and its subsidiaries a market leader in temperature-controlled storage and transportation solutions that enables the delivery of life-saving treatments across the globe. The cash purchase price to be paid at closing will be approximately €410 million. Additional cash consideration, up to €50 million, may be paid upon achievement of certain future performance milestones. The transaction is expected to close in October 2022.
B Medical is headquartered in Hosingen, Luxembourg and is one of the leading vaccine cold chain providers serving primarily fast-growing emerging markets, which require secure and reliable temperature-controlled storage and transport solutions. The portfolio includes vaccine transport systems with real-time monitoring solutions, medical refrigeration for ambient to -86°C temperatures, and blood management solutions. B Medical has an installed base of more than 500,000 units spanning approximately 150 countries across the globe. The Luxembourg headquarters includes a state-of-the-art, highly automated manufacturing facility.
This acquisition complements Azenta's cold chain capabilities, adding differentiated solutions for reliable and traceable transport of temperature-sensitive specimens.
"We are excited to add B Medical into our growing portfolio of offerings. B Medical has done an outstanding job carving out a strong market position in the vaccine cold chain, and we see a breadth of opportunities to drive even further value from the portfolio by leveraging the Azenta platform."
Steve Schwartz, President and CEO of Azenta
B Medical CEO, Luc Provost, who has been with the company for over 20 years, and Jesal Doshi, Deputy CEO since 2015, are expected to join Azenta and continue to lead the business. Mr. Provost commented, "We are excited to join the Azenta team as we combine our capabilities and expertise in cold chain solutions to drive the next leg of growth. Together, I look forward to continuing our mission to create technology that helps save lives across the world."
B Medical generated approximately €109 million in revenue over the past twelve months ending June 30, 2022. Management expects the acquisition to be accretive to non-GAAP earnings in fiscal year 2023 and accretive to GAAP earnings in fiscal year 2024.
About B Medical Systems
B Medical is a global manufacturer and distributor of cold chain solutions. Based in Hosingen, Luxembourg, the company was founded in 1979, when the World Health Organization (WHO) approached Electrolux to provide a solution to safely store and transport vaccines around the world. The three major business portfolios include Vaccine Cold Chain, Medical Refrigeration, and Blood Management solutions. Notable products include vaccine transport systems (ice-lined and solar direct drive) with remote temperature monitoring devices, laboratory refrigerators, ultra-low freezers, contact-shock freezers, and transport solutions. B Medical Systems' products are used in approximately 150 countries and have an installed base of more than half a million products across the world.
About Azenta Life Sciences
Azenta, Inc. is a leading provider of life sciences solutions worldwide, enabling impactful breakthroughs and therapies to market faster. Azenta provides a full suite of reliable cold-chain sample management solutions and genomic services across areas such as drug development, clinical research and advanced cell therapies for the industry's top pharmaceutical, biotech, academic and healthcare institutions globally. As of December 1st, the company changed its name and ticker to Azenta, Inc.from Brooks Automation, Inc.